Designation:F2888−13StandardTestMethodforPlateletLeukocyteCount—AnIn-VitroMeasureforHemocompatibilityAssessmentofCardiovascularMaterials1ThisstandardisissuedunderthefixeddesignationF2888;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodassistsintheevaluationofcardiovas-culardevicematerialsfortheirabilitytoinducethrombusformation.Thrombusformationisassessedbymeansofareductioninhumanplateletsandleukocyteswhenconsumedbythrombusafteractivationonthematerialsurface.Thisassaymaybepartofthehemocompatibilityevaluationfordevicesandmaterialscontactinghumanblood,asperANSI/AAMI/ISO10993–4.SeealsoTestMethodF2382.1.2Allsafetypoliciesandpracticesshallbeobservedduringtheperformanceofthistestmethod.Allhumanbloodandanymaterialsthathadcontactwithhumanbloodshallbebaggedinabiohazardbag,properlylabeledasthecontents,anddisposedofbyappropriatemeans.1.3ThehumanbloodshouldbehandledatBiosafetyLevel2asrecommendedintheCentersforDiseaseControl/NationalInstitutesofHealthManualBiosafetyinMicrobiologicalLaboratories.Thehumanblooddonormusthavetestednega-tiveforHepatitisB(HBV)andHumanImmunodeficiency(HIV)viruses.Thebloodshouldbetreatedlikeanypatientbloodinusinguniversalprecautions.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.SomespecifichazardsstatementsaregiveninSection7onHazards.2.ReferencedDocuments2.1ASTMStandards:2F2382TestMethodforAssessmentofIntravascularMedicalDeviceMaterialsonPartialThromboplastinTime(PTT)2.2OtherStandards:ANSI/AAMI/ISO10993–4BiologicalEvaluation...
